510(k) · Cleared

Recalled · Class II · 2012

Stem Hip Replacement System, Model PHA002XX

K021346510(k) AbbreviatedCleared Jul 2, 200264-day reviewClass II21 CFR 888.3358Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jul 2, 2002 after a 64-day review. The FDA summary names no predicate by number. 19 later devices descend from it. It has been recalled 3 times.

Decided: Jul 2, 2002
Review: 64 days
Class: Class II
Product code: LPH
Recalls: 3
Predicates: 0

19 later devices descend from it, 11 citing it directly.

This deviceK021346 Stem Hip Replacement System, Model PHA002XXWrightmedicaltechnologyinc · 2002
Descendant · cites it directly · 8 of its ownK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
Descendant · cites it directly · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
Descendant · 2 generations on · 4 of its ownK150302 PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015
Descendant · cites it directly · 4 of its ownK112150 Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011
Descendant · 2 generations on · 3 of its ownK150133 PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc. · 2015

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2011high 6 (2011) · low 0 (2014)2026

Most influential descendants

Showing 5 of 19 · See all

K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly8descendants
K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly5descendants
K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc. · 2015 · 2 generations on4descendants
K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly4descendants
K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc. · 2015 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021346	Stem Hip Replacement System, Model PHA002XX	Wrightmedicaltechnologyinc	2002	—
+1	K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	—
+1	K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	—
+2	K150302	PROFEMUR Preserve Classic Stem	Microport Orthopedics, Inc.	2015	—
+1	K112150	Profemur Gladiator HA Hip Stem	Wrightmedicaltechnologyinc	2011	—
+2	K150133	PROFEMUR Preserve Size 1-3 Hip Stems	Microport Orthopedics, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	6	0
2012	2	0
2013	2	0
2015	2	0
2018	1	0
2020	2	0
2022	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K021346, 2002–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (19)

See all 19

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112080	Preserve Hip Stem	Wrightmedicaltechnologyinc	2011	8
K111910	Gladiator Hip Stem	Wrightmedicaltechnologyinc	2011	5
K112150	Profemur Gladiator HA Hip Stem	Wrightmedicaltechnologyinc	2011	4
K121221	Profemur Z Revision Hip Stem	Wrightmedicaltechnologyinc	2012	3
K111699	Profemur (R) Z Titanium Plasma Sprayed Hip Stem	Wrightmedicaltechnologyinc	2011	3
K123434	Profemur Z Classic Stems	Wrightmedicaltechnologyinc	2013	2
K111698	Profemur (R) E Cementless Hip Stem	Wrightmedicaltechnologyinc	2011	2
K110399	Gladiator Plasma Classic Hip Stem	Wrightmedicaltechnologyinc	2011	2
K173898	MicroPort Orthopedics Total Hip Systems MR Labeling	Microport Orthopedics Inc. (Mpo)	2018	1
K130149	U2 Hip System, Expanded Indications for Use	United Orthopedic Corporation	2013	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 5, 2012	Class II	Z-0183-2013	Packaging process control	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Sep 5, 2012	Class II	Z-0184-2013	Packaging process control	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Sep 5, 2012	Class II	Z-0185-2013	Packaging process control	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K112080 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 8 descendants of its own.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2) Inflammatory degenerative joint disease such as rheumatoid arthritis;

3) Correction of functional deformity;

4) Revision procedures where other treatments or devices have failed; and,

5) Treatment of fractures that are unmanageable using other techniques.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021346 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021346: Stem Hip Replacement System, Model PHA002XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021346

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026